title: Immunogenicity and safety of an indigenously developed DTPw hepatitis B combination vaccine in Indian infants.
abstract: OBJECTIVE
  To evaluate the safety and immunogenicity of an indigenous hepatitis B, diphtheria, tetanus and B. pertussis tetravalent vaccine (Shantetra) in comparison with Tritanrix HBTM in healthy Indian infants.
  
  
  METHODS
  Multicentric, randomized, single blind intention-to-treat study with 12-18 weeks of follow up period.
  
  
  METHODS
  5 out patient departments at tertiary care referral centers across India.
  
  
  METHODS
  151 infants were randomized in a 2:1 ratio to recruit 101 in the Shantetra and 50 in the Tritanrix HBTM groups respectively. A total of 136 subjects completed the study. No patients were withdrawn from the study due to any adverse effects.
  
  
  METHODS
  Recruited subjects were randomized to receive three doses of either of the two DTPw-Hepatitis B combination vaccines as per the EPI schedule.
  
  
  METHODS
  Monitoring the humoral immune response (seroconversion rates) induced by each antigenic component three to six weeks after the last dose of vaccine in both the groups.
  
  
  RESULTS
  Seroprotective immune response was observed in 98.9% subjects for diphtheria, tetanus and hepatitis B components in the Shantetra group as compared to 95.5% subjects in the Tritanrix HB group. Anti pertussis antibody response was seen in 89% and 91.1% in the Shantetra and Tritanrix HB groups, respectively. The commonly observed adverse events in both the groups were, pain at injection site, mild fever and transient crying.
  
  
  CONCLUSIONS
  The safety and immunogenicity of indigenously developed DTPwHepatitis B combination vaccine was demonstrated in the present study.
authors.affiliation: Department of Pediatrics, Shardaben General Hospital and Smt NHL Municipal Medical College, Ahmedabad, India. rajucshah@gmail.com
authors.forename: Raju
authors.initials: R
authors.lastname: Shah
authors.forename: M B
authors.initials: MB
authors.lastname: Raghu
authors.forename: A
authors.initials: A
authors.lastname: Shivananda
authors.forename: S
authors.initials: S
authors.lastname: Mangayarkarasi
authors.forename: I
authors.initials: I
authors.lastname: Rao
authors.forename: R
authors.initials: R
authors.lastname: Rao
authors.forename: P
authors.initials: P
authors.lastname: Bhusari
authors.forename: C A
authors.initials: CA
authors.lastname: Joseph
authors.forename: R
authors.initials: R
authors.lastname: Reddy
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007194:India; D007223:Infant; D016037:Single-Blind Method; D017778:Vaccines, Combined
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D017325:Hepatitis B Vaccines; C524362:Tritanrix-HepB vaccine; D017778:Vaccines, Combined